KR101709045B1 - Detachable coupling for catheter - Google Patents
Detachable coupling for catheter Download PDFInfo
- Publication number
- KR101709045B1 KR101709045B1 KR1020160140818A KR20160140818A KR101709045B1 KR 101709045 B1 KR101709045 B1 KR 101709045B1 KR 1020160140818 A KR1020160140818 A KR 1020160140818A KR 20160140818 A KR20160140818 A KR 20160140818A KR 101709045 B1 KR101709045 B1 KR 101709045B1
- Authority
- KR
- South Korea
- Prior art keywords
- coupling
- tubular body
- microcatheter
- tip body
- tip
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
- B29C66/737—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined
- B29C66/7379—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined degradable
- B29C66/73791—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined degradable biodegradable
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
- B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
- B29C66/91411—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
- B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
- B29C66/91411—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
- B29C66/91413—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account the parts to be joined having different temperatures
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
- B29K2995/0037—Other properties
- B29K2995/0056—Biocompatible, e.g. biopolymers or bioelastomers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/041—Controlled or regulated
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
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Abstract
본 발명은 긴 가요성 튜브형 본체, 팁 본체 및 커플링을 포함하는 마이크로카테터에 관한 것이다. 상기 긴 가요성 튜브형 본체는 기저 단부, 말단 단부, 및 긴 가요성 튜브형 본체를 통해 축방향으로 연장하는 하나 이상의 내강을 갖는다. 상기 팁 본체는 기저 단부, 말단 단부, 및 팁 본체를 통해 축방향으로 연장하는 내강을 갖는다. 상기 커플링은 튜브형 본체 및 팁 본체 둘 다의 일부를 커버하고, 제1 물질 및 제2 물질로부터 제조되며, 여기서 제1 물질은 제2 물질과 상이하다. 상기 제1 물질은 튜브형 본체의 최외각 층 및 팁 본체의 최외각 층과 상용성이고, 상기 제2 물질은 튜브형 본체 및 팁 본체 중 하나 이상과 분리가능한 결합을 형성하도록 구성된다.The present invention relates to a micro-catheter comprising a long flexible tubular body, a tip body and a coupling. The elongated flexible tubular body has a base end, a distal end, and at least one lumen extending axially through the elongate flexible tubular body. The tip body has a base end, a distal end, and a lumen extending axially through the tip body. The coupling covers a portion of both the tubular body and the tip body and is made from a first material and a second material, wherein the first material is different from the second material. The first material is compatible with the outermost layer of the tubular body and the outermost layer of the tip body, and the second material is configured to form a detachable bond with at least one of the tubular body and the tip body.
Description
본 발명은 일반적으로 마이크로카테터, 및 특히 분리가능한 생체적합성 팁을 구비한 마이크로카테터에 관한 것이다.The present invention relates generally to microcatheters, and in particular to microcatheters with detachable biocompatible tips.
마이크로카테터는 일반적으로 대퇴 동맥과 같은 혈관을 통해 신체내로 삽입되고, 맥관내에서 다양한 용도를 갖는다. 마이크로카테터를 이용하여 동정맥 기형(AVM) 및 동맥류와 같은 각종 신경혈관 질환의 치료를 돕는데 사용할 수 있다.Microcatheters are generally inserted into the body through blood vessels such as the femoral artery and have a variety of uses in the veins. Can be used to assist in the treatment of various neurovascular diseases such as arteriovenous malformations (AVM) and aneurysms using microcatheters.
동맥류 및 AVM은, 뇌동맥류 및 뇌동정맥기형으로의 혈류를 영구적으로 폐색시키기 위해 마이크로카테터를 통해 전달되어 생체내에서 고화되는 조성물에 의해 맥관내에서 치료될 수 있다. 적합한 맥관내 조성물에는 단지 예로서, 생체내에서 중합되어 고체 덩어리를 형성하는 시아노아크릴레이트뿐만 아니라, 디메틸 술폭시드("DMSO")와 같은 비-수성 용매 중에 용해된 맥관구조 내로 도입시에 DMSO는 소멸되고 중합체는 수계 혈액 조성물 중에 침전되는, 생체적합성 수 불용성 중합체의 용액이 포함된다. 이러한 맥관내 조성물에는 형성된 덩어리의 가시화를 보조하기 위한 조영제가 더 포함된다.Aneurysms and AVMs can be treated in the vasculature by compositions that are delivered through a microcatheter and solidify in vivo to permanently occlude the blood flow to the cerebral aneurysm and cerebral arteriovenous malformations. Suitable intrathecal compositions include, by way of example only, cyanoacrylates that are polymerized in vivo to form solid masses, as well as DMSOs (such as DMSO) at the time of introduction into the vasculature dissolved in non-aqueous solvents such as dimethyl sulfoxide ("DMSO & Insoluble polymer that is dissolved in water and the polymer is precipitated in the water-based blood composition. Such intra-vascular compositions further include a contrast agent to assist visualization of the formed mass.
색전 조성물은 마이크로카테터로부터 색전술 부위로 전달된다. 색전 조성물은 생체내에서 고화되기 때문에 조성물의 "역류" 또는 "환류"가 일어나면 마이크로카테터의 말단 팁이 그 내부에 포획될 수 있다. 이러한 일이 발생하는 경우, 임상의는 강제로 마이크로카테터를 회수하기 위해 시도하거나(종종 마이크로카테터의 파손을 초래함), 또는 환자의 맥관내에 말단 팁을 남겨둔 채 카테터를 절단해야 한다.The embolization composition is delivered from the microcatheter to the embolization site. Because the embolization composition is solidified in vivo, the distal tip of the microcatheter can be trapped therein when "reflux" or "reflux" of the composition occurs. When this happens, the clinician must forcefully attempt to retrieve the microcatheter (often resulting in breakage of the microcatheter) or cut the catheter leaving the distal tip in the patient's vasculature.
미국 특허출원 공개공보 US2010/0049165호(Sutherland 등)는 분리 가능한 팁을 포함하는 마이크로카테터를 개시하고 있다. United States Patent Application Publication No. US2010 / 0049165 (Sutherland et al.) Discloses a microcatheter comprising a detachable tip.
따라서, 본 개시내용은, 말단 팁이 어떠한 이유로든 맥관내에 포획되는 경우 이러한 문제에 의해 초래되는 잠재적인 위험을 최소화하면서, 환자에게서 안전하게 제거될 수 있는 마이크로카테터의 제공에 관한 것이다.Accordingly, the present disclosure is directed to providing a microcatheter that can be safely removed from a patient, while minimizing the potential risk incurred by such a problem if the distal tip is trapped in the vessel for any reason.
본 개시내용은 긴 가요성 튜브형 본체, 팁 본체 및 커플링을 포함하는 마이크로카테터에 관한 것이다. 상기 긴 가요성 튜브형 본체는 기저 단부, 말단 단부, 및 긴 가요성 튜브형 본체를 통해 축방향으로 연장하는 하나 이상의 내강을 갖는다. 상기 팁 본체는 기저 단부, 말단 단부, 및 팁 본체를 통해 축방향으로 연장하는 내강을 갖는다. 상기 커플링은 튜브형 본체 및 팁 본체 둘 다의 일부를 커버하고, 제1 물질 및 제2 물질로부터 제조되며, 여기서 제1 물질은 제2 물질과 상이하다. 상기 제1 물질은 튜브형 본체의 최외각 층 및 팁 본체의 최외각 층과 상용성이다. 상기 제2 물질은 튜브형 본체 및 팁 본체 중 하나 이상과 분리가능한 결합을 형성하도록 구성된다.The present disclosure relates to a micro-catheter comprising a long flexible tubular body, a tip body and a coupling. The elongated flexible tubular body has a base end, a distal end, and at least one lumen extending axially through the elongate flexible tubular body. The tip body has a base end, a distal end, and a lumen extending axially through the tip body. The coupling covers a portion of both the tubular body and the tip body and is made from a first material and a second material, wherein the first material is different from the second material. The first material is compatible with the outermost layer of the tubular body and the outermost layer of the tip body. The second material is configured to form a releasable engagement with at least one of the tubular body and the tip body.
개시된 실시형태에서, 제1 물질은 제2 물질의 반경방향 외향에, 예를 들어 제2 물질의 전체 길이를 따라 배치된다. 본원에서는, 제1 물질이 제2 물질의 반경방향 외향에 제1 물질의 전체 길이를 따라 배치되는 것이 개시되어 있다.In the disclosed embodiment, the first material is disposed radially outward of the second material, for example along the entire length of the second material. In the present application it is disclosed that the first material is disposed along the entire length of the first material in the radially outward direction of the second material.
개시된 실시형태에서, 제2 물질은 튜브형 본체와 직접적으로 접촉한다.In the disclosed embodiment, the second material is in direct contact with the tubular body.
개시된 실시형태에서, 제1 물질은 폴리우레탄, 폴리에틸렌, 폴리테트라플루오로에틸렌(PTFE), 팽창된 폴리테트라플루오로에틸렌(EPTFE), 폴리에테르 블록 아미드, 폴리비닐 클로라이드(PVC) 및 폴리프로필렌으로 이루어지는 군으로부터 선택된다. 개시된 실시형태에서, 제2 물질은 저밀도 폴리에틸렌(LDPE), 선형 저밀도 폴리에틸렌(LLDPE) 및 고밀도 폴리에틸렌(HDPE)으로 이루어지는 군으로부터 선택된다. 본원에서, 튜브형 본체가 제1 물질로부터 제조되는 것이 개시되어 있다.In the disclosed embodiment, the first material is a material comprising polyurethane, polyethylene, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyether block amide, polyvinyl chloride Lt; / RTI > In the disclosed embodiment, the second material is selected from the group consisting of low density polyethylene (LDPE), linear low density polyethylene (LLDPE) and high density polyethylene (HDPE). In the present application, it is disclosed that the tubular body is made from a first material.
개시된 실시형태에서, 제3 물질이 제1 물질과 제2 물질 사이에 배치된다.In the disclosed embodiment, a third material is disposed between the first material and the second material.
개시된 실시형태에서, 제1 물질은 친수성 코팅과 상용성이다.In the disclosed embodiment, the first material is compatible with the hydrophilic coating.
개시된 실시형태에서, 커플링은 단일 유닛이다.In the disclosed embodiment, the coupling is a single unit.
개시된 실시형태에서, 친수성 코팅이 포함되고, 튜브형 본체, 팁 본체 및 제1 물질과 접촉한다.In the disclosed embodiment, a hydrophilic coating is included and contacts the tubular body, the tip body, and the first material.
개시된 실시형태에서, 친수성 코팅은 튜브형 본체, 팁 본체 및 제1 물질과 접촉한다.In the disclosed embodiment, the hydrophilic coating contacts the tubular body, the tip body and the first material.
본 개시내용은 또한 튜브형 본체, 팁 본체 및 커플링을 포함하는 마이크로카테터에 관한 것이다. 상기 튜브형 본체는 기저 부분, 말단 부분, 및 유동제를 도입하기 위해 기저 부분에서 말단 부분까지 연장하는 내강을 갖는다. 상기 튜브형 본체는 제1 물질로부터 제조된다. 상기 팁 본체는 튜브형 본체의 말단 부분에 결합하고, 튜브의 내강과 연통하는 중앙 내강을 형성한다. 상기 커플링은 제1 결합을 통해 튜브형 본체의 일부와 결합하고, 제2 결합을 통해 팁 본체의 일부와 결합한다. 상기 커플링은 제1 물질 및 제2 물질을 포함하는 2가지 이상의 상이한 물질로부터 제조된다. 상기 제1 결합 및 제2 결합은 상이한 결합 강도를 갖는다.The present disclosure also relates to a microcatheter comprising a tubular body, a tip body and a coupling. The tubular body has a base portion, a distal portion, and a lumen extending from the base portion to the distal portion for introducing fluidizing agent. The tubular body is made from a first material. The tip body is coupled to a distal end portion of the tubular body and forms a central lumen communicating with the lumen of the tube. The coupling engages a portion of the tubular body through the first engagement and engages a portion of the tip body through the second engagement. The coupling is made from two or more different materials comprising a first material and a second material. The first and second bonds have different bond strengths.
개시된 실시형태에서, 제1 결합은 제2 결합보다 강하다.In the disclosed embodiment, the first coupling is stronger than the second coupling.
개시된 실시형태에서, 제1 물질은 폴리우레탄, 폴리에틸렌, 폴리테트라플루오로에틸렌(PTFE), 팽창된 폴리테트라플루오로에틸렌(EPTFE), 폴리에테르 블록 아미드, 폴리비닐 클로라이드(PVC) 및 폴리프로필렌으로 이루어지는 군으로부터 선택된다. 개시된 실시형태에서, 제2 물질은 저밀도 폴리에틸렌(LDPE), 선형 저밀도 폴리에틸렌(LLDPE) 및 고밀도 폴리에틸렌(HDPE)으로 이루어지는 군으로부터 선택된다.In the disclosed embodiment, the first material is a material comprising polyurethane, polyethylene, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyether block amide, polyvinyl chloride Lt; / RTI > In the disclosed embodiment, the second material is selected from the group consisting of low density polyethylene (LDPE), linear low density polyethylene (LLDPE) and high density polyethylene (HDPE).
본 개시내용은 또한 마이크로카테터의 제조 방법에 관한 것이다. 본 방법은 기저 단부, 말단 단부, 및 긴 가요성 튜브형 본체를 통해 축방향으로 연장하는 하나 이상의 내강을 갖는 긴 가요성 튜브형 본체를 제공하는 것을 포함한다. 본 방법은 또한 기저 단부, 말단 단부, 및 팁 본체를 통해 축방향으로 연장하는 내강을 갖는 팁 본체를 제공하는 것을 포함한다. 본 방법은, 제1 물질이 제2 물질과 상이하고 제1 물질이 튜브형 본체의 최외각 층 및 팁 본체의 최외각 층과 상용성인, 제1 물질 및 제2 물질로부터 제조된 커플링을 제공하는 것을 더 포함한다. 본 방법은 또한 튜브형 본체의 일부 및 커플링의 일부를 가열하여 그들 사이에 제1 결합을 형성하고, 팁 본체의 일부 및 커플링의 일부를 가열하여 그들 사이에 제2 결합을 형성하는 것을 포함한다. 제1 결합과 제2 결합은 상이한 결합 강도를 갖는다.The present disclosure also relates to a method of making a microcatheter. The method includes providing a long flexible tubular body having a base end, a distal end, and at least one lumen extending axially through the elongate flexible tubular body. The method also includes providing a tip body having a base end, a distal end, and a lumen extending axially through the tip body. The method provides a coupling made from a first material and a second material, wherein the first material is different from the second material and the first material is compatible with the outermost layer of the tubular body and the outermost layer of the tip body . The method also includes heating a portion of the tubular body and a portion of the coupling to form a first coupling therebetween, and heating a portion of the tip body and a portion of the coupling to form a second coupling therebetween . The first bond and the second bond have different bond strengths.
본 개시내용은, 말단 팁이 어떠한 이유로든 맥관내에 포획되는 경우 이러한 문제에 의해 초래되는 잠재적인 위험을 최소화하면서, 환자에게서 안전하게 제거될 수 있는 마이크로카테터를 제공합니다. The present disclosure provides a microcatheter that can be safely removed from a patient while minimizing the potential hazards caused by such problems if the terminal tip is trapped in the vessel for any reason.
본 개시내용의 실시형태는 하기 도면을 참조로 하여 쉽게 이해될 것이다:
도 1은 본 개시내용에 따른 카테터의 측면 평면도이고;
도 2는 튜브형 본체, 팁 본체 및 커플링을 예시하는 도 1의 카테터 일부의 투시도이고;
도 3 및 4는 본 개시내용의 원리에 따라 환자 맥관의 구불구불한 영역 내에서의 사용되는 도 1 및 2의 카테터를 예시하고;
도 5는 본 개시내용에 따른 커플링의 제1 실시형태의 종방향 단면도이고;
도 5a는 선 5A-5A에 따른 도 5의 커플링의 횡방향 단면도이고;
도 5b는 선 5B-5B에 따른 도 5의 커플링의 횡방향 단면도이고;
도 6은 본 개시내용에 따른 커플링의 제2 실시형태의 종방향 단면도이고;
도 6a는 선 6A-6A에 따른 도 6의 커플링의 횡방향 단면도이고;
도 6b는 선 6B-6B에 따른 도 6의 커플링의 횡방향 단면도이고;
도 7은 본 개시내용에 따른 커플링의 제3 실시형태의 종방향 단면도이고;
도 7a는 선 7A-7A에 따른 도 7의 커플링의 횡방향 단면도이고;
도 7b는 선 7B-7B에 따른 도 7의 커플링의 횡방향 단면도이다.BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the present disclosure will be readily understood with reference to the following drawings:
1 is a side plan view of a catheter according to the present disclosure;
Figure 2 is a perspective view of the catheter portion of Figure 1 illustrating a tubular body, a tip body, and a coupling;
Figures 3 and 4 illustrate the catheters of Figures 1 and 2 used in the serpentine area of the patient's vasculature in accordance with the principles of the present disclosure;
5 is a longitudinal cross-sectional view of a first embodiment of a coupling according to the present disclosure;
5A is a cross-sectional side view of the coupling of FIG. 5 taken along
Figure 5b is a cross-sectional side view of the coupling of Figure 5 according to
Figure 6 is a longitudinal sectional view of a second embodiment of the coupling according to the present disclosure;
6A is a cross-sectional side view of the coupling of FIG. 6 taken along
Figure 6b is a cross-sectional side view of the coupling of Figure 6 according to
7 is a longitudinal cross-sectional view of a third embodiment of the coupling according to the present disclosure;
FIG. 7A is a cross-sectional side view of the coupling of FIG. 7 taken along
7B is a cross-sectional side view of the coupling of FIG. 7 taken along
하기 기재에서, 본원에서 사용된 용어 "기저" 및 "말단"은 내강에서의 마이크로카테터의 상대적인 위치를 지칭한다. 마이크로카테터의 "기저" 또는 "후단(trailing)" 단부는 임상의에게서 가장 근접하여 신체 외부에서 연장되는 마이크로카테터 세그먼트이다. 마이크로카테터의 "말단" 또는 "선단(leading)" 단부는 진입 부위로부터 가장 멀리 신체 내강에 위치하는 마이크로카테터 세그먼트이다.In the following description, the terms "base" and "distal ", as used herein, refer to the relative position of the microcatheter in the lumen. The "underlying" or "trailing" end of the microcatheter is a microcatheter segment that extends out of the body closest to the clinician. The "distal" or "leading" end of the microcatheter is a microcatheter segment located in the body lumen farthest from the entry site.
도 1을 참조하면, 마이크로카테터(10)는 환자의 맥관 부위로 색전 제제를 전달하는데에 유용할 수 있다. 마이크로카테터는 신체의 임의의 혈관에 사용될 수 있으나, 특히 신경혈관(neurovasculature)에서의 동맥류 또는 AVM의 색전에 유용하다. 마이크로카테터(10)는, 종방향 축 "a"를 형성하고 말단 또는 선단 단부(12) 및 기저 또는 후단 단부(14)를 갖는 튜브형 본체 세그먼트(16)를 포함한다. 마이크로카테터(10)는 튜브형 본체(16)와 동축이고 커플링(100)을 통해 튜브형 본체(16)와 분리가능하게 연결 또는 결합되는 팁 본체(30)를 더 포함한다. 용어 "분리가능하게 결합되는" 또는 "분리가능하게 연결되는"은 마이크로카테터(10)의 의도하는 용도에 따라, 설정값일 수 있는 후퇴력(retraction force)의 적용시에 팁 본체(30)가 튜브형 본체(16)로부터 결합 해제될 수 있다는 해석을 포함하고자 하는 것이다. 예를 들어, 설정된 힘은 종방향 축 "a"를 따라 튜브형 본체(16), 팁 본체(30) 또는 커플링(100) 중 적어도 하나에 적용되는 인장력일 수 있다. 다른 실시형태에서, 설정된 힘은 부품에 적용되는 전단력 또는 반경방향 힘일 수 있다. 용어 "후퇴력"은 일반적으로 마이크로카테터(10)의 종방향 축을 따라, 예를 들어 중앙 내강(22)과 평행하게 기저 방향으로, 즉 환자에게서 마이크로카테터를 회수하는 방향으로 적용되는 인장력이다. 팁 본체(30)로부터 튜브형 본체(16)를 분리하기 위해 이용되는 후퇴력은, 예를 들어 약 160 그램-힘 이하일 수 있고, 보다 특히 약 10 그램-힘 내지 약 160 그램-힘의 범위일 수 있다. 특정 실시형태에서, 후퇴력은 약 20 그램-힘 내지 약 40 그램-힘이다. 다른 실시형태에서, 후퇴력은 약 30 그램-힘 내지 약 50 그램-힘이다. 또한, 상기 기재된 범위 이외의 범위도 이용될 수 있다. 커플링(100)의 각종 실시형태가 본원 하기에 더 상세히 논의될 것이다.Referring to Figure 1, the
도 1 및 2를 참조하면, 튜브형 본체(16) 및 팁 본체(30)는 외부 및 내부 직경이 동일하거나 상이할 수 있다. 마이크로카테터(10)의 기저 단부(14)는 매니폴드(18)를 포함할 수 있다. 매니폴드(18)는 긴 중앙 내강(22)에 의해 말단 접근 포트(24)와 유체 연통하는 하나 이상의 접근 포트(20)를 포함할 수 있다. 중앙 내강(22)에 의해 마이크로카테터(10)는 유도와이어(도시되지 않음)를 따르게 된다. 유도와이어의 제거 후, 중앙 내강(22)을 사용하여 색전 제제를 원하는 맥관 부위로 전달할 수 있다. 구체적으로 예시되지는 않았으나, 마이크로카테터(10)는 복수의 내강을 함유할 수 있다. 예를 들어, 하나의 내강은 유도와이어에 의해서 사용될 수 있는 한편, 또다른 내강은 색전 제제의 전달에 사용될 수 있다. 마이크로카테터(10)는 튜브형 본체(16)의 말단 단부(12)에 인접하여 위치한 마커(32), 예를 들어 방사선불투과성 마커를 포함할 수 있다. 마커(32)는 금속 또는 금속 합금, 예를 들어 백금, 백금/이리듐, 금, 니티놀 등으로부터 제조된 고리 또는 밴드일 수 있다. 개시된 실시형태에서, 커플링(100)은 방사성불투과성 물질, 예를 들어 황산바륨으로 충전될 수 있다.Referring to Figures 1 and 2, the
원하는 맥관 부위로의 색전 제제의 전달을 추가로 보조하기 위해, 팁 본체(30)는 임의로 복수의 측방향 개구부 또는 홀(38)을 함유할 수 있다. 개구부(38)의 형태는 둥근형, 타원형 또는 다른 형태 중에서 선택될 수 있다.The
마이크로카테터(10)의 총 길이는, 다른 범위도 가능하지만, 일반적으로 약 150 cm 내지 약 175 cm의 범위일 수 있다. 튜브형 본체(16)는, 다른 직경도 가능하지만, 약 0.5 mm 내지 약 1.5 mm 범위 이내의 외부 직경을 갖도록 선택될 수 있다. 일부 실시형태에서, 중앙 내강(22)의 직경은, 사용되는 경우, 유도와이어의 외부 직경보다 더 큰 약 0.002 인치 내지 약 0.005 인치일 수 있다. 이러한 직경은 기저 및 말단 단부에서 적절하게 수정될 수 있다. 본원에 기재된 치수 이외의 다른 치수들이 마이크로카테터(10)의 의도하는 용도에 특히 적합하도록 본원의 개시내용의 측면에서 당업자에 의해 용이하게 이용될 수 있다.The total length of the
튜브형 본체(16)는 각종 물질로 또한 각종 방식으로 구성될 수 있다. 튜브형 본체(16)가 폴리우레탄, 폴리에틸렌, 폴리테트라플루오로에틸렌(PTFE), 팽창된 폴리테트라플루오로에틸렌(EPTFE), 폴리에테르 블록 아미드(상표가 피벡스. RTM(Pebax.RTM)인 것들이 포함됨), 폴리비닐 클로라이드(PVC) 및 폴리프로필렌으로 이루어지는 군으로부터 선택된 물질로부터 제조된다는 것이 구상된다. 개시된 실시형태에서, 튜브형 본체(16)는 디메틸술폭시드와 상용성인 물질로 구성될 수 있다. 또한, 튜브형 본체(16)는 이용되는 구성 방법 및 물질에 의해서도 조절될 수 있는 다양한 가요성을 가진 영역을 함유할 수도 있다. 또한, 튜브형 본체(16)는 각종 중합체, 예를 들어 폴리이미드, 폴리테트라플루오로에틸렌, 폴리에테르 블록 아미드, 폴리아미드 등의 적층에 의해서도 구성될 수 있다. 튜브형 본체(16)는 또한 각종 피치(pitch)의 브레이드(braid)를 포함할 수도 있다. 팁 본체(30)는 생체적합성 물질로부터 제조된다. "생체적합성"이란 적용된 양의 물질이 환자의 맥관에서 사용되는 경우 실질적으로 비-독성이며 실질적으로 비-면역원성임을 의미한다. 예를 들어, 팁 본체(30)가 폴리우레탄, 폴리에틸렌, 폴리테트라플루오로에틸렌(PTFE), 팽창된 폴리테트라플루오로에틸렌(EPTFE), 폴리에테르 블록 아미드, 폴리비닐 클로라이드(PVC) 및 폴리프로필렌으로 이루어지는 군으로부터 선택된 물질로부터 제조되는 것이 구상된다. 또한, 팁 본체(30)가 튜브형 본체(16)와 동일한 물질로부터 제조되는 것도 구상된다.The
특정 실시형태에서, 팁 본체(30)는 또한 "생체분해성"일 수도 있다. 마이크로카테터 팁의 구성에 유용한 광범위한 생체분해성/생체침식성(bioerodable) 및 비-생체분해성 물질이 알려져 있다. 팁 본체(30)는 동일계(in situ)에서 생체분해성 또는 생체흡수성인 물질로 형성될 수 있다. 생체분해성 또는 생체흡수성 물질, 또는 이들의 일부 조합을 사용하여 설정된 조건에서 생체분해/생체흡수되도록 한다.In certain embodiments, the
각종 생체적합성-생체분해성 물질이 시판되어 있고, 이러한 실시형태들에 사용하기에 적합하다. 이러한 물질의 예에는 DLPLA--폴리(dl-락티드), LPLA--폴리(l-락티드), PGA--폴리글리콜리드 , PDO--폴리(디옥사논), PGA-TMC--폴리(글리콜리드-co-트리메틸렌 카르보네이트), PGA-LPLA--폴리(l-락티드-co-글리콜리드), PGA-DLPLA--폴리(dl-락티드-co-글리콜리드), LPLA-DLPLA--폴리(l-락티드-co-dl-락티드), 및 PDO-PGA-TMC--폴리(글리콜리드-co-트리메틸렌 카르보네이트-co-디옥사논)이 포함된다.Various biocompatible-biodegradable materials are commercially available and are suitable for use in these embodiments. Examples of such materials include, but are not limited to, DLPLA poly (dl-lactide), LPLA poly (l-lactide), PGA polyglycolide, PDO poly (Glycolide-co-trimethylenecarbonate), PGA-LPLA-poly (l-lactide-co-glycolide), PGA-DLPLA-poly (dl- -DLPLA-poly (l-lactide-co-dl-lactide), and PDO-PGA-TMC-poly (glycolide-co-trimethylene carbonate-co-dioxanone).
또한, 윤활 코팅이 튜브형 본체(16), 커플링(100) 및 팁 본체(30)를 포함하는 마이크로카테터(10)의 부품 상에 배치될 수 있다는 것이 구상된다. 적합한 윤활 코팅에는 폴리비닐피롤리돈(PVP), 폴리에틸렌 옥시드, 폴리에틸렌 글리콜, 셀룰로오스성 중합체 및 친수성 말레산 무수물과 같은 친수성 물질, 또는 실리콘, PTFE, 또는 FEP와 같은 소수성 물질이 포함된다. 이러한 코팅은 일반적으로 침지 코팅 또는 분무 방법에 의해 적용되고, 가열 또는 자외선(UV) 경화도 이용될 수 있다. 예를 들어, 약 섭씨 70도 이하의 경화 온도가 실리콘 코팅에 이용되고, 섭씨 수백도가 PTFE 코팅에 요구될 수 있다. 윤활 코팅뿐만 아니라, 생체활성 코팅을 마이크로카테터의 전체 또는 일부에 적용할 수도 있다. 이러한 코팅은 또한 헤파린, 히루딘 및 그의 유사체, 또는 다른 약물과 같은 물질을 포함할 수도 있다. 이러한 코팅은 일반적으로 침지 코팅에 의해 적용된다. 생체활성 코팅은 혈액 응고의 방지를 위해 또는 특정 부위로의 약물의 전달을 위해 바람직하다.It is also contemplated that a lubricating coating may be disposed on the part of the
커플링(100)의 각종 실시형태가 첨부 도면에 도시되어 있다. 도 5 내지 도 5b를 참조하면, 커플링(100a)의 제1 실시형태가 도시되어 있다. 커플링(100a)은 제1 물질(110a) 및 제2 물질(120a)로부터 제조된다. 또한, 임의의 제3 물질(130a)이 제1 물질(110a)과 제2 물질(120a) 사이에 도시되어 있고, 제3 물질을 사용하여 그들 사이의 결합을 형성할 수 있다. 도 5 내지 도 5b를 예시한 실시형태에서, 제1 물질(110a) 및 제2 물질(120a)은 커플링(100a)의 전체 길이 "L"만큼 연장되어 있다. 또한, 제1 물질(110a)은 커플링(100a)의 전체 길이 "L"을 따라 제2 물질(120a)의 반경방향 외향에 배치된다.Various embodiments of the
커플링(100a)의 제1 물질(110a)은 상기 기재된 바와 같이 튜브형 본체(16)의 최외각 층 및 팁 본체(30)의 최외각 층, 예컨대 친수성 코팅과 상용성인 물질을 포함하는 것으로 구상된다. 이해될 수 있는 바와 같이, 친수성 코팅과 상용성인 물질은, 침지, 스폰지 코팅, 분무 또는 당업계에 공지되어 있는 임의의 다른 통상적인 코팅 기술에 의해 친수성 코팅이 부착될 수 있는 물질을 포함한다. 예를 들어, 제1 물질(110a)에는 폴리우레탄, 폴리에틸렌, 폴리테트라플루오로에틸렌(PTFE), 팽창된 폴리테트라플루오로에틸렌(EPTFE), 폴리에테르 블록 아미드, 폴리비닐 클로라이드(PVC) 또는 폴리프로필렌이 포함되는 것으로 구상된다. 또한, 제1 물질(110a)은 튜브형 본체(16)가 제조된 물질과 동일한 것으로 구상된다.The
커플링(100a)의 제2 물질(120a)에 관해서는, 제2 물질(120a)이 튜브형 본체(16)와의 결합 및 팁 본체(30)와의 분리가능한 결합을 형성할 수 있는 물질을 포함하는 것으로 구상된다. 따라서, 커플링(100a)의 제2 물질(120a)에는, 예를 들어 저밀도 폴리에틸렌(LDPE), 선형 저밀도 폴리에틸렌(LLDPE) 또는 고밀도 폴리에틸렌(HDPE)이 포함되는 것으로 구상된다. 튜브형 본체(16)가 팁 본체(30)와 동일한 물질로부터 제조되는 실시형태에서는, 예를 들어 상이한 온도에서 결합을 가열함으로써 상이한 결합 강도를 갖는 결합의 형성이 달성되는 것으로 구상된다. 예를 들어, 튜브형 본체(16)와 커플링(100a) 간의 상대적으로 강한 결합을 제공하기 위해, 예를 들어 약 350℉ 내지 약 354℉의 온도에서, 예를 들어 약 7초 동안 영역을 가열함으로써 상기 결합을 생성할 수 있고; 팁 본체(30)와 커플링(100a) 간의 상대적으로 약한 결합을 제공하기 위해, 예를 들어 약 246℉ 내지 약 250℉의 온도에서, 예를 들어 약 6초 동안 영역을 가열함으로써 상기 결합을 생성할 수 있다.With regard to the
따라서, 개시된 실시형태에서, 커플링(100a)은 커플링(100a)과 팁 본체(30)를 연결하는 결합 강도에 비해 상대적으로 강한 결합을 통해 튜브형 본체(16)에 부착된다. 이러한 실시형태에서, 임상의에 의해 적용되는 적합한 후퇴력은, 커플링(100a)을 팁 본체(30)로부터 분리시키면서, 커플링(100a)은 튜브형 본체(16)에 연결되어 남아있게 한다. 이해될 수 있는 바와 같이, 강한 결합 및 약한 결합은 원하는 결과에 따라 전환시킬 수 있다. 개시된 실시형태에서, 제1 물질(110a)은 폴리에테르 블록 아미드이고, 제2 물질(120a)은 저밀도 폴리에틸렌이고, 튜브형 본체(16)의 적어도 일부는 폴리에테르 블록 아미드이다.Thus, in the disclosed embodiment, the
또한, 제1 물질(110a)과 제2 물질(120a) 간의 결합을 형성하기 위해 사용될 수 있는 제3 물질(130a)은 플렉사르(Plexar), TYMAX™, 또는 듀퐁(Dupont)™ Bynel®로부터 제조될 수 있다. 특히, 제1 물질(110a)이 피벡스로부터 제조되고 제2 물질(120a)이 LDPE로부터 제조되는 경우, 제3 물질(130a)은 플렉사르로부터 제조되는 것으로 구상된다.Also, the
도 6 내지 도 6b를 참조로 하면, 커플링(100)의 제2 실시형태가 도시되어 있고, 커플링(100b)으로서 도시되어 있다. 커플링(100b)은 제1 물질(110b) 및 제2 물질(120b)로부터 제조된다. 도시된 바와 같이, 제1 물질(110b)은 제2 물질(120b)의 전체 길이를 따라 제2 물질(120b)의 반경방향 외향에 배치된다. 또한, 제1 물질(110b)과 제2 물질(120b) 간의 구별선(140b)이 존재하여 제2 물질(120b)이 커플링(100b) 길이 "L"의 일부만큼만 연장된다. 구별선(140b)이 커플링(100b)의 종방향 중심점 근처에 도시되어 있는 한편, 구별선(140b)이 도시된 위치보다 더 기저에 또는 더 말단에 위치되어 있는 것도 구상된다. 또한, 제1 물질(110b)은 제1 물질(110a)과 동일한 물질 군으로부터 선택되고, 제2 물질(120b)은 제2 물질(120a)과 동일한 물질 군으로부터 선택된다. 또한, 명백히 예시하지는 않았지만, 제3 물질은 제1 물질(110b)과 제2 물질(120b) 사이에 배치될 수 있고, 제3 물질(130a)과 동일한 물질(들)을 포함할 수도 있다.Referring to Figures 6 to 6B, a second embodiment of the
도 7 내지 도 7b를 참조로 하면, 커플링(100)의 제3 실시형태가 도시되어 있고, 커플링(100c)으로서 도시되어 있다. 커플링(100c)은 제1 물질(110c) 및 제2 물질(120c)로부터 제조된다. 도시된 바와 같이, 제1 물질(110c) 전체는 제2 물질(120c) 전체에 대해 기저측에 배치되어 있다. 또한, 제1 물질(110c)과 제2 물질(120c) 간의 구별선(140c)이 존재한다. 구별선(140c)은 커플링(100c)의 종방향 중심점 근처에 또한 튜브형 본체(16)와 팁 본체(30)의 연결부에 인접하여 도시되어 있으나, 구별선(140c)이 도시된 위치보다 더 기저에 또는 더 말단에 위치되어 있는 것도 구상된다. 또한, 제1 물질(110c)이 제1 물질(110a)과 동일한 물질 군으로부터 선택되고, 제2 물질(120c)이 제2 물질(120a)과 동일한 물질 군으로부터 선택되는 것도 구상된다. 또한, 명백히 예시하지는 않았지만, 제3 물질은 제1 물질(110c)과 제2 물질(120c) 사이에 배치될 수 있고, 제3 물질(130a)과 동일한 물질 군으로부터 선택될 수 있다.Referring to Figs. 7 to 7B, a third embodiment of the
도 3을 다시 참조하면, 인간 신체내에서의 마이크로카테터(10)의 용도가 예시되어 있다. 구체적으로는, 마이크로카테터(10)는 서혜부(groin)와 같은 편리한 위치에서 환자에게로 삽입된다. 마이크로카테터(10)는, 팁 본체(30)가 AVM 또는 동맥류와 같은 치료 부위(40)에 도달할 때까지 맥관을 통해 진행된다. 마이크로카테터(10)의 위치는 방사선불투과성 마커(32)를 가시화함으로써 모니터링할 수 있다. 마이크로카테터(10)가 맥관내의 그의 적합한 위치에 있게 되면, 색전 제제(42)가 치료 부위(40)로 전달될 수 있다. 색전 제제(42)는 액상 색전 제제일 수 있고, 다수의 물질로 구성될 수 있다. 적합한 색전 제제(42)에는 계내 중합될 수 있는 생체적합성 중합체 및 예비중합체를 함유하는 것들이 포함된다. 액상 색전 제제는 또한 생체적합성 용매 및 조영제를 포함할 수도 있다. 일 실시형태에서, 조영제는 수-불용성이다. 이러한 하나의 실시예로는 캐나다 어바인 소재의 타이코 헬스케어 그룹 엘피 디비에이 코비디엔(Tyco Healthcare Group LP dba Covidien)으로부터 시판되는, DMSO(디메틸 술폭시드) 중 용해된 EVOH(에틸렌 비닐 알콜) 공중합체 및 현탁 미분된 탄탈 분말로 구성되어 형광투시법 하에서 가시화하기 위한 조영을 제공하는 비-접착성 액상 색전 제제인 Onyx™가 있다. 적합한 색전 제제에 대한 추가의 설명이 본원에 모두 참조로 포함되고 본 명세서의 일부를 구성하는 미국 특허 제5,667,767호; 제5,695,480호; 제6,051,607호; 제6,342,202호; 제6,531,111호; 및 제6,562,317호에 기재되어 있다.Referring again to Fig. 3, the use of the
도 3 및 도 4를 참조로 하면, 색전 제제(42)의 전달 후, 팁 본체(30)가 제제(42) 내에 포획될 수 있다. 환자에게서 이러한 마이크로카테터(10)를 제거하기 위해, 주치의는 후퇴력을 튜브형 본체(16)에 적용할 수 있다. 일반적으로, 후퇴력이 적용되는 경우, 커플링(100)은 1) 팁 본체(30)에 부착되어 남아있을 수 있거나; 2) 튜브형 본체(16)에 부착되어 남아있을 수 있거나; 또는 3) 2가지 부품으로 분해됨으로써 튜브형 본체(16) 및 팁 본체(30) 둘 다에 부분적으로 부착되어 남아있을 수 있다.3 and 4, after delivery of
힘을 적용한 후의 커플링(100)의 상태는, 부품의 구성 물질에 의해 또한 팁 본체(30) 및 튜브형 본체(16)로의 커플링(100)의 결합에 사용된 방법에 의해 영향을 받을 수 있다. 커플링(100)으로의 팁 본체(30)의 결합 및 커플링(100)으로의 튜브형 본체(16)의 결합은 다양한 방식으로 달성될 수 있다. 예를 들어, 커플링(100)은 튜브형 본체(16)의 말단 단부(34)와 중첩될 수 있고/거나, 팁 본체(30)의 기저 단부(36)와 중첩될 수 있다(도 2 참조). 중첩되는 양은 팁 본체(30)를 분리하기 위해 이용되는 후퇴력을 결정하는 인자가 될 수 있다. 일부 실시형태에서, 팁 본체(30) 또는 튜브형 본체(16)로의 커플링(100)의 하나 또는 둘 다로의 부착은 맞대기 이음(butt joint)(단부 대 단부)일 수 있다. 일부 실시형태에서, 말단 단부(34) 및 기저 단부(36)는 맞대기 이음을 형성할 수 있다.The state of the
본 개시내용은 또한 본원에 개시된 것으로서 마이크로카테터(10) 및/또는 커플링(100)의 제조 방법에 관한 것이다. 따라서, 마이크로카테터(10)와 함께 사용하기 위한 커플링(100)이 공압출을 통해 또는 몰드(예를 들어, 몰딩 또는 오버몰딩)로부터 제조되는 것이 구상된다. 또한, 상기 논의된 바와 같이, 커플링(100)을 고온 결합을 통해 카테터(10)에 결합시키는 것이 구상된다. 특히, 약 350℉ 내지 약 354℉의 온도로 약 7초 동안 커플링(100)/튜브형 본체(16)를 가열함으로써 커플링(100)을 튜브형 본체(16)에 결합시킬 수 있고, 약 246℉ 내지 약 250℉의 온도로 약 6초 동안 커플링(100)/팁 본체(30)를 가열함으로써 커플링(100)을 팁 본체(30)에 결합시킬 수 있다. 열 공급원을 적용할 때, 커플링(100)은 기계적 결합(더 작은 튜브형 본체(16) 및 팁 본체(30) 주위에서 열 수축하는 힘) 또는 용융 결합(커플링(100), 튜브형 본체(16), 및/또는 팁 본체(30)의 물질이 함께 용융됨)에 의해 튜브형 본체(16) 및 팁 본체(30)에 부착될 수 있다.The present disclosure also relates to a method of manufacturing the
별법의 구성 방법에서는, 접착제, 열풍, 레이저, 고온 다이, 플라즈마 처리 또는 용매 결합을 이용함으로써 커플링(100)을 팁 본체(30) 및/또는 튜브형 본체(16)에 부착시킬 수 있다.Alternatively, the
또한, 커플링(100)을 튜브형 본체(16) 및/또는 팁 본체(30)와 다양한 양으로 중첩시킬 수 있는 것이 구상된다. 중첩되는 양은, 팁 본체(30)를 튜브형 본체(16) 및/또는 커플링(100)으로부터 분리하기 위해 요구되는 후퇴력에 대한 하나의 인자일 수 있다. 예를 들어, 튜브형 본체(16) 및/또는 팁 본체(30) 상에서 커플링(100)이 더 많이 중첩될수록, 2개의 부품을 분리하기 위해 더 큰 후퇴력이 필요하게 되는 것이 구상된다. 일부 실시형태에서, 이러한 중첩은 약 0.5 mm 내지 약 5 mm일 수 있다. 일부 실시형태에서, 중첩은 약 2 mm 내지 약 4 mm일 수 있다. 다른 중첩 범위도 가능하다.It is also contemplated that the
상기 기재 및 도면은 본 개시내용의 실시형태를 기재하기 위한 목적으로 제공되었으며, 어떤 식으로든 본 개시내용의 범주를 제한하고자 하는 것은 아니다. 예를 들어, 커플링(100a 내지 100c)의 각 실시형태는 팁 본체(30)와 접촉하는 튜브형 본체(16)를 예시하지만, 그들 사이에 공간이 존재하는 것도 구상된다. 당업자에게는 각종 개질 및 변형이 본 개시내용의 취지 또는 범주를 벗어나지 않으면서 이루어질 수 있음이 명백할 것이다. 따라서, 본 개시내용은 본 개시내용의 개질 및 변형을 포함하되, 본 개시내용의 개질 및 변형이 첨부된 특허청구범위 및 그의 등가물의 범주 내에 있도록 하고자 하는 것이다.The foregoing description and drawings are provided for the purpose of describing the embodiments of the present disclosure and are not intended to limit the scope of the present disclosure in any way. For example, each embodiment of the
Claims (19)
기저 단부, 말단 단부, 및 축방향으로 연장하는 내강을 갖는 팁 본체;
튜브형 본체 및 팁 본체 둘 다의 일부를 커버하며, 제1 물질 및 제1 물질과 상이한 제2 물질로 제조되고, 제1 물질과 제2 물질 사이에 구별선을 포함하는 커플링; 및
적어도 커플링 및 팁 본체에 적용된 친수성 코팅을 포함하고,
제1 물질은 친수성 코팅과 상용성이고,
제2 물질은 튜브형 본체 및 팁 본체 중 하나 이상과 분리가능한 결합을 형성하도록 구성되고,
커플링의 제1 물질은 튜브형 본체와 직접 접촉하고 팁 본체와는 직접 접촉하지 않는,
마이크로카테터.A long flexible tubular body having a base end, a distal end, and at least one axially extending lumen;
A tip body having a base end, a distal end, and an axially extending lumen;
A coupling that covers a portion of both the tubular body and the tip body and is made of a first material and a second material different from the first material, the coupling comprising a separation line between the first material and the second material; And
At least a coupling and a hydrophilic coating applied to the tip body,
The first material is compatible with the hydrophilic coating,
Wherein the second material is configured to form a releasable engagement with at least one of the tubular body and the tip body,
The first material of the coupling being in direct contact with the tubular body and not in direct contact with the tip body,
Microcatheter.
튜브형 본체의 말단 부분에 결합하고, 튜브형 본체의 내강과 연통하는 중앙 내강을 형성하는 팁 본체;
제1 결합을 통해 튜브형 본체의 일부와 결합하고, 제2 결합을 통해 팁 본체의 일부와 결합하고, 제1 물질 및 제2 물질을 포함하여 2가지 이상의 상이한 물질로 제조되고, 제1 물질과 제2 물질 사이에 구별선을 포함하는 커플링 - 제1 결합 및 제2 결합은 상이한 결합 강도를 갖고, 커플링의 제1 물질은 튜브형 본체와 직접 접촉하고 팁 본체와는 직접 접촉하지 않음 -; 및
적어도 커플링 및 팁 본체에 적용되는 친수성 코팅을 포함하고,
제1 물질은 친수성 코팅과 상용성인,
마이크로카테터. A tubular body made of a first material, the tubular body having a base portion, a distal portion, and a lumen extending from the base portion to the distal portion for introducing the fluidizing agent;
A tip body coupled to a distal end portion of the tubular body and defining a central lumen communicating with the lumen of the tubular body;
Wherein the first and second materials are joined to a portion of the tubular body through a first bond and coupled to a portion of the tip body through a second bond and made of two or more different materials including a first material and a second material, Wherein the first material of the coupling is in direct contact with the tubular body and is not in direct contact with the tip body; And
At least a hydrophilic coating applied to the coupling and the tip body,
The first material is compatible with the hydrophilic coating,
Microcatheter.
팁 본체의 일부 및 커플링의 일부 사이에 제2 결합을 형성하도록 팁 본체의 일부 및 커플링의 일부를 가열하는 단계 - 팁 본체는 기저 단부, 말단 단부, 및 축방향으로 연장하는 내강을 갖고, 제1 결합 및 제2 결합은 상이한 강도를 갖고, 커플링의 제1 물질은 튜브형 본체와 직접 접촉하고 팁 본체와는 직접 접촉하지 않음 -; 및
커플링, 튜브형 본체 및 팁 본체에 친수성 코팅을 적용하는 단계를 포함하고,
커플링의 제1 물질은 친수성 코팅과 상용성인,
마이크로카테터의 제조 방법.Heating a portion of the elongated flexible tubular body and a portion of the coupling to form a first engagement between a portion of the elongated flexible tubular body and a portion of the coupling, the elongated flexible tubular body having a proximal end, Wherein the coupling is made of a first material and a second material, wherein the first material is different from the second material, and the coupling has a line of separation between the first material and the second material include -;
Heating a portion of the tip body and a portion of the coupling to form a second engagement between a portion of the tip body and a portion of the coupling, the tip body having a base end, a distal end, and an axially extending lumen, The first and second couplings having different intensities, the first material of the coupling being in direct contact with the tubular body and not in direct contact with the tip body; And
Applying a hydrophilic coating to the coupling, tubular body and tip body,
The first material of the coupling is compatible with the hydrophilic coating,
A method of manufacturing a microcatheter.
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US13/526,611 US10124087B2 (en) | 2012-06-19 | 2012-06-19 | Detachable coupling for catheter |
US13/526,611 | 2012-06-19 |
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US (1) | US10124087B2 (en) |
EP (1) | EP2676696B1 (en) |
JP (1) | JP2014000399A (en) |
KR (2) | KR20130142933A (en) |
CN (1) | CN103505793B (en) |
BR (1) | BR102013015313A2 (en) |
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- 2013-05-14 RU RU2013122046/14A patent/RU2013122046A/en not_active Application Discontinuation
- 2013-05-29 EP EP13169745.0A patent/EP2676696B1/en active Active
- 2013-06-06 JP JP2013119620A patent/JP2014000399A/en active Pending
- 2013-06-18 CN CN201310240253.1A patent/CN103505793B/en active Active
- 2013-06-18 BR BRBR102013015313-3A patent/BR102013015313A2/en not_active IP Right Cessation
- 2013-06-18 KR KR1020130069432A patent/KR20130142933A/en active Application Filing
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CA2815040A1 (en) | 2013-12-19 |
RU2013122046A (en) | 2014-11-20 |
US20130338643A1 (en) | 2013-12-19 |
CN103505793A (en) | 2014-01-15 |
JP2014000399A (en) | 2014-01-09 |
EP2676696B1 (en) | 2016-08-03 |
KR20130142933A (en) | 2013-12-30 |
CA2815040C (en) | 2016-09-13 |
US10124087B2 (en) | 2018-11-13 |
CN103505793B (en) | 2016-08-10 |
EP2676696A1 (en) | 2013-12-25 |
KR20160130350A (en) | 2016-11-11 |
BR102013015313A2 (en) | 2015-06-23 |
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